Application 207923

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SEEBRI	GLYCOPYRROLATE	POWDER;INHALATION	15.6MCG/INH	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N207923-001	SEEBRI NEOHALER	GLYCOPYRROLATE	15.6MCG/INH	POWDER / INHALATION		RLD	2015-10-29

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N207923-001	8479730	2028-10-11		Drug product	2015-12-04
N207923-001	8182838	2028-10-20		Drug product	2015-12-04

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N207923-001	SEEBRI NEOHALER	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N207923-001	SEEBRI NEOHALER	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N207923-001	SEEBRI NEOHALER	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207923-001	SEEBRI NEOHALER	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N207923-001	SEEBRI NEOHALER	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207923-001	SEEBRI	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207923-001	SEEBRI	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207923-001	SEEBRI	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207923-001	SEEBRI	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207923-001	SEEBRI	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207923-001	SEEBRI	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N207923-001	SEEBRI	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207923-001	SEEBRI	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207923-001	SEEBRI	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207923-001	SEEBRI	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N207923-001	SEEBRI	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207923-001	SEEBRI	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N207923-001	SEEBRI	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N207923-001	SEEBRI	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N207923-001	SEEBRI	15.6MCG/INH	POWDER / INHALATION	RLD, RS	2015-10-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N207923-001	SEEBRI	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N207923-001	SEEBRI	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N207923-001	SEEBRI	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N207923-001	SEEBRI	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N207923-001	SEEBRI	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N207923-001	SEEBRI	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N207923-001	SEEBRI	15.6MCG/INH	POWDER / INHALATION	RLD, RS	2015-10-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N207923-001	SEEBRI	15.6MCG/INH	POWDER / INHALATION	RLD, RS	2015-10-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N207923-001	SEEBRI	15.6MCG/INH	POWDER / INHALATION	RLD, RS	2015-10-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N207923-001	SEEBRI	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N207923-001	SEEBRI	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N207923-001	SEEBRI	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N207923-001	SEEBRI	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N207923-001	SEEBRI	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N207923-001	SEEBRI	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N207923-001	SEEBRI	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N207923-001	SEEBRI	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N207923-001	SEEBRI	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N207923-001	SEEBRI	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N207923-001	SEEBRI	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`f41ea6bd6efb…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N207923-001	8479730	2028-10-11		Drug product	2015-12-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207923-001	8182838	2028-10-20		Drug product	2015-12-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N207923-001	8479730	2028-10-11		Drug product	2015-12-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207923-001	8182838	2028-10-20		Drug product	2015-12-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N207923-001	8479730	2028-10-11		Drug product	2015-12-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207923-001	8182838	2028-10-20		Drug product	2015-12-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207923-001	8479730	2028-10-11		Drug product	2015-12-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207923-001	8182838	2028-10-20		Drug product	2015-12-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N207923-001	8479730	2028-10-11		Drug product	2015-12-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207923-001	8182838	2028-10-20		Drug product	2015-12-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207923-001	8479730	2028-10-11		Drug product	2015-12-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207923-001	8182838	2028-10-20		Drug product	2015-12-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207923-001	8479730	2028-10-11		Drug product	2015-12-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207923-001	8182838	2028-10-20		Drug product	2015-12-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207923-001	8479730	2028-10-11		Drug product	2015-12-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207923-001	8182838	2028-10-20		Drug product	2015-12-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207923-001	8479730	2028-10-11		Drug product	2015-12-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207923-001	8182838	2028-10-20		Drug product	2015-12-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207923-001	8479730	2028-10-11		Drug product	2015-12-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207923-001	8182838	2028-10-20		Drug product	2015-12-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207923-001	8479730	2028-10-11		Drug product	2015-12-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207923-001	8182838	2028-10-20		Drug product	2015-12-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N207923-001	8479730	2028-10-11		Drug product	2015-12-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N207923-001	8182838	2028-10-20		Drug product	2015-12-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207923-001	8479730	2028-10-11		Drug product	2015-12-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207923-001	8182838	2028-10-20		Drug product	2015-12-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207923-001	8479730	2028-10-11		Drug product	2015-12-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207923-001	8182838	2028-10-20		Drug product	2015-12-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207923-001	8479730	2028-10-11		Drug product	2015-12-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207923-001	8182838	2028-10-20		Drug product	2015-12-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N207923-001	8479730	2028-10-11		Drug product	2015-12-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N207923-001	8182838	2028-10-20		Drug product	2015-12-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207923-001	8479730	2028-10-11		Drug product	2015-12-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207923-001	8182838	2028-10-20		Drug product	2015-12-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N207923-001	8479730	2028-10-11		Drug product	2015-12-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N207923-001	8182838	2028-10-20		Drug product	2015-12-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N207923-001	8479730	2028-10-11		Drug product	2015-12-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N207923-001	8182838	2028-10-20		Drug product	2015-12-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N207923-001	7229607	2021-04-09	U-1773		2015-12-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N207923-001	8029768	2021-04-09	U-1773		2015-12-04	`74a2ff9319b5…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 3 of 6 · 115 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glycopyrrolate	GLYCOPYRROLATE	Accord Healthcare, Inc.,	871797f0-697a-4a29-a37b-d06219e8f266	2025-10-17	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Henry Schein, Inc.	8b4d1798-c0a7-4661-99cd-1e9a23c16386	2025-10-16	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Hikma Pharmaceuticals USA Inc.	960d2dd0-008d-4ec1-ba2e-9388b28b23e2	2025-10-09	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	ProPharma Distribution	3f2b4281-55f3-43e3-e063-6294a90a56ba	2025-09-18	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
GLYCOPYRROLATE	GLYCOPYRROLATE	ProPharma Distribution	3edcc39d-0e29-4585-e063-6394a90ad512	2025-09-15	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	ProPharma Distribution	3edd6a26-dd0f-2411-e063-6394a90affa2	2025-09-15	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Alembic Pharmaceuticals Inc.	327f8a9e-7730-4f38-a7aa-fbddebddf173	2025-08-26	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Precision Dose, Inc.	e58f860b-e955-4d71-a128-93bd3812b08d	2025-08-08	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
GLYRX-PF	GLYCOPYRROLATE	Exela Pharma Sciences, LLC	2189f3f5-39dc-4e85-b7c6-9515ded59686	2025-07-23	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
GLYCOPYRROLATE	GLYCOPYRROLATE	QUAGEN PHARMACEUTICALS LLC	a456eaea-4cd6-4344-8fc6-6f6a3ce0f2c6	2025-06-14	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
GLYCOPYRROLATE	GLYCOPYRROLATE	American Health Packaging	6404fc8e-d109-4950-9dca-c8a85ad90cf3	2025-05-18	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Leading Pharma, LLC	498bce66-6072-4212-8413-ff9888c58f9c	2025-04-25	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Chartwell RX, LLC	89090b34-470c-478c-be49-1d2bc48a28f8	2025-04-17	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
GLYCOPYRROLATE	GLYCOPYRROLATE	Aurobindo Pharma Limited	4b3f8b3e-6fa8-471b-8bee-3dac5e3ea1b8	2025-04-17	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	AvPAK	bd497783-e2d1-130c-e053-2995a90a7fb9	2025-03-04	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Caplin Steriles Limited	765490fa-8378-40c8-9fa7-b0bfa2e1a0a9	2025-01-25	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
GLYCOPYRROLATE	GLYCOPYRROLATE	HF Acquisition Co LLC, DBA HealthFirst	9a3a142c-daaf-79af-e053-2995a90a1c51	2025-01-08	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
GLYCOPYRROLATE	GLYCOPYRROLATE	HF Acquisition Co LLC, DBA HealthFirst	9bde90dd-0300-f705-e053-2a95a90a7ea6	2025-01-08	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Bryant Ranch Prepack	d93a9b2b-708d-4db5-8aae-45fd3a7ca65c	2025-01-06	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
Cuvposa	GLYCOPYRROLATE	Merz Pharmaceuticals, LLC	d200bd44-9856-4104-a29e-a4cca3db6737	2024-12-19	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0078-0662	SEEBRI NEOHALER	glycopyrrolate	Novartis Pharmaceuticals Corporation	NDA	Current
63402-815	SEEBRI NEOHALER	GLYCOPYRROLATE	Sunovion Pharmacueticals Inc.	NDA	Current
63402-815	SEEBRI NEOHALER	GLYCOPYRROLATE	Sunovion Pharmacueticals Inc.	NDA	Current
63402-815	SEEBRI NEOHALER	GLYCOPYRROLATE	Sunovion Pharmacueticals Inc.	NDA	Current
63402-815	SEEBRI NEOHALER	GLYCOPYRROLATE	Sunovion Pharmacueticals Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
68251	SUPPL	2021-08-02
68244	SUPPL	2021-08-02
46945	SUPPL	2017-01-24
46942	SUPPL	2017-01-24
46078	ORIG	2016-12-06
46028	ORIG	2016-12-06
32864	ORIG	2015-11-03
19972	ORIG	2015-11-03